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- 2026-04-17 03:16:38
- Policy
- Chong Kun Dang's own brand botulinum sales countdown
- by Lee, Tak-Sun Apr 23, 2020 06:27am
- Chong Kun Dang's anti-wrinkle agent botulinum toxin will be released to the market soon after receiving national lot release. In the meantime, Chong Kun Dang has been selling Hugel's brand 'Botulax', but it ended the contract last year and prepared to sell its own brand. According to the industry on the 22nd, Chong Kun Dang secured the rights of the botulinum toxin formulation 'Wondertox 100 units' (Clostridium botulinum toxin type A) through the transfer with Huons at the end of last year. Wondertox was approved by Huons in August of last year, but the rights were transferred to Chong Kun Dang through the transfer. Instead, production is undertaken by Huons Global, a holding company. Huons Global has a separate botulinum formulation 'Liztox' (Export name: Hutox). National lot release is a system that approves sales after conducting data screening and tests for vaccines, botulinum preparations, and plasma fraction preparations. National lot release means that it can be sold on the market. As soon as Wondertox passed final step, it is expected to start selling through the hospital soon. The reason for interest in Chong Kun Dang's botulinum toxin is that Chong Kun Dang previously collaborated with Hugel to sell botulinum toxin 'Botulax', which significantly increased its market share. Since 2014, Chong Kun Dang has signed a joint sales contract for 'Botulax' with Hugel and has been selling products until June of last year. With the sale of Chong Kun Dang, Botulax won the market by surpassing Medytox with sales of about ₩50 billion in the domestic market. This is the result of taking full advantage of Chong Kun Dang's largest sales force, the largest in Korea. Sale for Botulax ended, but Chong Kun Dang gained sales experience instead. As a result, Wondertox is expecting to settle in the market early through sales staffs who have accumulated sales experience. Moreover, Medytoxin by Medytox, which had a predominant sales rate, was banned due to suspicion of manipulation. Taking advantage of this, Wondertox was able to expand its customers. The participation of Chong Kun Dang and the ban on the sale of Medytox is expected to change the market for the domestic botulinum toxin market. It is noted who will be the final winner in the domestic market worth about ₩100 billion.
- Policy
- Atnahs is insisting on infringement against generics
- by Lee, Tak-Sun Apr 23, 2020 06:26am
- Generic for Bonviva , an osteoporosis treatment drug launched in 2012, was lately caught up in a patent dispute. This is because the changed patent holder is insisting on infringement of indications and dosage patents against generics. According to the industry on the 21st, Atnahs, UK, which took over the patent right of Bonviva from Roche in 2018, filed a lawsuit against patent infringement in domestic generic company A. It is known that the patent infringement lawsuit is still ongoing. In response, domestic pharmaceutical companies have also filed a patent invalidation trial since March. Following the first judgment on March 10 by Theragen Etex, Cho-A Pharm, Wooridul Pharmaceutical, Arlico Pharmaceutical, Kolmar Korea, Huvist, Ildong Pharmaceutical, Hana Pharmaceutical, and Hyundai Pharmaceutical joined. An official at a pharmaceutical company that filed patent invalidity said that he claimed alleged patent infringement against generic company A because the new patent holder filed a patent invalidation lawsuit. This patent relates to indications and dosage of Bonviva. It is for taking 150mg once a day at least 1 hour before eating food in the morning. In Korea, the advancing indications and dosage patents are not recognized, but in the 2015 Supreme Court agreement, they are recognized as a new component of the invention of medical use. At the time of the release of generics in 2012, indications and dosage patents were not a problem for market sales. Earlier, the official said that when launching generics, it was obvious that indications and dosage patent would be invalidated, but it was in the dispute after acknowledging the patent in Korea. Currently, there are about 40 pharmaceutical companies that have the same ingredients (Ibandronate Sod.) generics such as Bonviva. Therefore, it is an analysis that the direction of patent invalidation judgment is important. Currently, Bonviva has a domestic copyright in Roche. The amount of outpatient prescriptions (Souce: UBIST) last year was ₩2.8 billion.
- Company
- Global companies made KRW 21M per employee last year
- by An, Kyung-Jin Apr 23, 2020 06:26am
- Korea Otsuka Pharmaceutical has generated the highest operating profit per employee last year among Korean branches of multinational pharmaceutical companies. Each employee at the multinational company has made 108 million won worth of operating profit. On Apr. 21, an analysis on 30 multinational pharmaceutical companies in Korea surveyed audit reports submitted to the Financial Supervisory Service (FSS) and found the companies operating profit per employee. Last year’s operating profit per employee in top multinational pharmaceutical companies (Unit: KRW 1 million) Source: FSS Last year, 30 Korean branches of multinational pharmaceutical companies have generated overall operating profit of 115.8 billion won with total 5,620 employees. Basically, respective employee has made average of 21 million won worth of operating profit, which is 10 million won less than in 2018 with 31 million won. Operating profit per employee in multinational companies in Korea is approximately a half of the figure in Korean pharmaceutical and bio companies. According to Daily Pharm’s survey on 30 companies with highest sales last year based on their business reports, each employee has generated average operating profit of 36.98 million won. Fundamentally, the pharmaceutical industry is considered as an industry with comparatively low operating profit. Its investment scale is exponential with R&D and sophisticated facilities, and the industry is actually labor-intensive with strong sales force. And Korean affiliates of multinational pharmaceutical companies have unique structure of supplying finished pharmaceutical product from overseas headquarters, which sometimes lowers profitability against sales volume due to high total cost of goods sold. Moreover, the profitability of many multinational companies in Korea is diminishing after their blockbuster drugs’ patents have expired, which also seems to have reduced operating profit per employee. Among the surveyed companies, only Korea Otsuka Pharmaceutical has made over 100 million won operating profit per employee. 357 employees of the multinational company combined have reached operating profit of 38.5 billion won. It adds to making operating profit of 108 million won per employee. Although the company’s healthcare product sales has been impacted by the Koreans boycotting Japanese goods, Korea Ostuka Pharmaceutical’s prescription drug sales has soared. First time since its establishment in Korea, its sales has marked 180 billion won and the operating profit was increased by 23.0 percent than the previous year. Korea Otsuka Pharmaceutical is one of a few multinational pharmaceutical companies with its own manufacturing facility in Korea. When Janssen Korea closes a plant in Hyangnam City, Korea Otsuka Pharmaceutical’s facility in Hyangnam City and Janssen Korea’s vaccine manufacturing plant in Songdo Bio Cluster would be the only two pharmaceutical manufacturing facilities in Korea owned by multinational companies. Generating 91 million won per employee last year, UCB Korea was ranked on the second place. As of late last year, the company reported the total number of employees was 36. Although the operating profit has gone down by 8.4 percent (30 million won) compared to 35.88 million won in 2018, UCB Korea has continued to make surplus with a limited number of employees and maintained the relatively higher productivity. Stuck in the reds for three consecutive years, GlaxoSmithKline (GSK) has turned around and finally generated surplus last year and made 18 million won per employee. The operating profit per employee in AbbVie Korea, Janssen Korea, Sanofi Pasteur, Allergan Korea and Guerbet Korea has grown by over 10 million won last year compared to the previous year. On the other hand, Alcon Korea has made operating profit of 2 million won per employee last year, not even reaching 10 million won. Menarini Korea, Janssen Vaccines, Galderma Korea, Roche Korea and Merck KGaA have ended up making deficit last year. Excluding the companies in the reds, 11 out of 23 surveyed companies have made operating profit per employee last year lower than the year before. In 2018, Sandoz Korea marked the highest operating profit per employee with 178 million won, but the figure plummeted last year and marked 31 million won per employee. Plunged by approximately 40 million won from 112 million won in 2018, Kyowa Kirin Korea has only made 74 million won operating profit per employee last year. As for Genzyme Korea, the operating profit in 2018 was at 62 million won per employee, but the last year’s figure was omitted from the report due to the merge with Sanofi-Aventis.
- Policy
- Samsung developed mobile blood pressure measurement app
- by Lee, Tak-Sun Apr 23, 2020 06:26am
- The MFDS (Chief Lee Eui-kyung) announced on the 20th that it approved the world's first software as a medical device (SaMD) that measures blood pressure using a 'mobile app'. This medical device is a 'blood pressure app' developed by 'Samsung Electronics Co., Ltd.'. It measures blood pressure easily by using a smart watch (mobile platform) on the wrist without wearing a cuff on the arm, and provides the user with a systolic/dilatolic blood pressure of the heart, and pulse rate reporting software. In particular, the MFDS explained that it satisfies both the blood pressure and pulse rate accuracy standards, which are the performance standards for medical devices of conventional automatic electronic blood pressure monitors. In order to promote the development of cutting-edge software medical device products, the MFDS held a round-table conference with mobile app companies in January of this year, listening to domestic and foreign product development trends and regulatory improvement needs. In February, the guidelines for safety management of mobile medical apps were revised so that only mobile apps can be authorized without permission for devices and devices used as mobile platforms, such as smartphones and tablet PCs. An official from the MFDS said that it expects the development of mobile platform-based software medical devices to become more active in the 4th industrial era, and will continue to support the rapid commercialization of medical devices with advanced technologies.
- Policy
- MSD, commercialize adult male oral HPV prevention vaccine
- by Lee, Tak-Sun Apr 22, 2020 06:04am
- Gardasil 9, MSDMSD conducts vaccine clinical trials to prevent oral HPV (human papillomavirus) infection in adult men. MSD has already introduced vaccines to prevent human papillomavirus through 'Gardasil · Gardasil9', but there are no indications for oral HPV prevention in adult men. The MFDS approved IND for phase III of an HPV vaccine (V503) submitted by MSD in Korea on the 20th. This clinical trial is aimed at the efficacy and immunity of the 9vHPV vaccine, a multivalent L1 virus-like particle vaccine in terms of HPV 16, 18, 31, 33, 45, 52, and 58 oral infections in adult males aged 20 to 45 years. This is a phase III, international, multicenter, randomized, double-blind, placebo-controlled clinical trial that evaluates originality and safety. The total number of subjects is 6000, and the number of domestic subjects is 250. MSD plans to conduct this clinical trial from December this year to January 2025. In Korea, Eunpyeong St. Mary's Hospital, Severance Hospital, Korea University Guro Hospital, HUMC-Kangnam Hospital, and Korea University Ansan Hospital participate. Human papillomavirus (HPV) causes papillomas in humans in the case of a virus that is infected through the skin or subcutaneous of an animal. It also causes cervical burden and testicular cancer. The most famous HPV vaccine in the world is MSD's Gardasil. The recently released Gardasil 9 prevents nine types of human papillomavirus and can be inoculated to women aged 9 to 26 and men aged 9 to 26. Gardasil is mainly used to prevent cervical disease in women, genital and anal diseases in men. However, HPV virus is also known to be the cause of infiltration into the oral cavity and larynx cancer mainly due to sexual intercourse. According to the HIRA, 2629 men were treated for oral cancer in 2018, an increase of about 33% compared to 2014. The exact cause of oral cancer is unknown, but smoking and drinking are the biggest risk factors, and are sometimes caused by the HPV virus. This clinical trial primarily evaluates vaccine efficacy against oral infections involving HPV 16, 18, 31, 33, 45, 52, and 58 that lasts more than 6 months, and secondly, it is a test to check the serum antibody titers, adverse reactions, etc. MSD's Gardasil 9 had a domestic sales of ₩40.5 billion, based on IQVIA last year, and is superior in the domestic HPV vaccine market. If indications are added, it is expected to have a significant impact on market expansion and sales growth.
- Company
- COVID-19 hinders Italian API distribution causing stock-out
- by Jung, Hye-Jin Apr 22, 2020 06:03am
- Due to temporary suspension of active pharmaceutical ingredient (API) distribution amid COVID-19 pandemic, many drugs have been reportedly sold out. The industry experts see that the restricted international logistics of human and material resources during the pandemic has affected a number of drugs to be stocked out for a long and short term. The latest stock-out news was from Conjuran injection 2 ml/ 1s. Indicated for treating arthritis pain, the injection is manufactured by Pharma Research Product. But the company says the restock would only be feasible after May at earliest as importing API has gotten extremely difficult with COVID-19. The active pharmaceutical ingredient of Conjuran is imported from Italy. Pharma Research has said the production line has been halted for the entire month of April, because of the ingredient export from the country has been shut down. Kuhnil Pharm’s diuretic Amilo tablet has recently been sold out. Amilo imports its API from India and manufactures intermediate product in China before it is imported to Korea. And drug struggled with the outbreak spreading in China and the lock down in India. Artemisia Princeps leaf extract, widely used as gastrointestinal agent, has also recently came out of the woods. The distribution of the leaf extract was temporarily stopped from the production facility in China, due to COVID-19. However, the ingredient stock-out was shortly resolved and distribution to Korea resumed soon after. Other items, such as Ilsung Pharm’s Ilsung Isoptin (40 mg and 80 mg/ 250 and 30 tablet packages), LG Chem’s Ralobon Plus (60 mg/ 30 tablet package), Samjin Pharm’s Gelma Suspension, Yuhan’s MG TNA 1053 ml injection, have recently notified their temporary stock-out. The affected companies have commonly explained they are facing difficulties in importing active ingredients, which ultimately caused the stock-out. Although they cannot pinpoint at COVID-19 as a direct cause, the pharmaceutical companies view the outbreak has either directly or indirectly influenced the logistics between countries for past three months. A pharmaceutical industry insider commented, “Usually a drug stock-out is caused by a delay in finished product import, but lately it has been mostly caused by trouble in ingredient distribution.” “Nowadays, importing pharmaceutical ingredients from China, India and even from Europe has become unstable with the lock down orders,” the insider added.
- Policy
- Controversy over Rutatera's exclusion from disaster expenses
- by Lee, Jeong-Hwan Apr 22, 2020 06:02am
- It has been pointed out that the NHIS is causing economic damage to patients by not applying disaster medical expenses to anticancer drugs for the treatment of rare tumors, which has greatly increased the cost of medication due to the COVID-19 pandemic. The NHIS announced that it was unable to apply disaster medical expenses for the reason that Rutatera, a neuroendocrine tumor treatment drug, was not permitted to be marketed in Korea. The association criticized it as an unreasonable and underfounded measure. The reason for this controversy is that the cost of a single dose of the treatment is about ₩26 million, and the cost is estimated at about ₩104 million when the treatment cycle is 4 times. On the 20th, the Korea alliance of patients organization issued a statement and urged that the NHIS should support Rutatera's disaster medical expenses. Rutatera obtained a commercial license from the US Food and Drug Administration (FDA) on January 26, 2018. The MFDS designated this drug as an emergency drug on November 28, last year. However, it has not yet been officially approved, but the MFDS is designating it as a orphan drug in December of last year, according to a request for marketing permission from Novartis Korea. As a result, domestic patients receive this drug from overseas through the KOEDC. The controversy over the disaster medical expenses started with the rejection of the request by the NHIS for Rutatera's disaster medical expenses, patient A with a neuroendocrine tumor in Korea, purchased from the KOEDC. It is known that the NHIS rejected Mr. A's application because Rutatera was not officially approved and is still in clinical trials. Particularly, patients who are burdened with the cost of administering Rutatera 1 cycle (4 injections) of more than ₩104 million receive overseas expeditions to Malaysia for administration of Lutetium that are similar to Rutatera. The situation in which expedition treatment was difficult with the COVID-19 Pandemic also contributed to the controversy over the rejection of disaster medical expenses. With expedition treatment, the cost of administering Lutetium is reduced to about ₩32 million to ₩40 million per cycle, but The Korea alliance of patients organization's position is that patients have to take risks such as medical accidents and serious safety accidents, and even COVID-19 outbreak has made it difficult. As a result, the Korea alliance of patients organization strongly emphasized the need for Rutatera to support disaster medical expenses. The opinion that the decision of the NHIS is different from that of the disaster medical expenses support project and contrary to the purpose of enacting the law. The Korea alliance of patients organization pointed out that patient A was planning to do so after receiving an answer from the staff of the Siheung branch of the NHIS that the drug cost of Rutatera, which was purchased at the KOEDC, can be supported as disaster medical expenses from ₩20 million to ₩30 million a year, but the NHIS took a position that the drug cannot be applied because it is in clinical trials. The organization said that this is different from the contents of the disaster medical expenses business and does not comply with the law, and the government-issued booklet includes medicines purchased from the KOEDC as targets for support. The association stressed that Rutatera is currently completing phase II clinical trials in Korea and is in the process of reviewing permits, and the NHIS needs to reconsider its complaints about rejection. Meanwhile, this statement was jointly presented by the Korean Association of Neuroendocrine Tumor (KANT) along with the Korea alliance of patients organization.
- Company
- GSK Korea pays the highest average salary at KRW 136M
- by An, Kyung-Jin Apr 22, 2020 06:02am
- Among all Korean affiliates of multinational pharmaceutical companies, employees at GlaxoSmithKline (GSK) Korea have received the highest average salary of 136 million won. Employees working at Sanofi Pasteur, GSK Consumer Healthcare Korea, Galderma Korea, Allergan Korea, Boehringer Ingelheim Korea and AbbVie Korea have received average salary of over 100 million won. Average salary per employee at major multinational pharmaceutical companies in 2019 (Unit: 1 million won) Source: FSS On Apr. 18, an analysis of 31 audit reports submitted to Financial Supervisory Service (FSS) by multinational pharmaceutical companies found GSK’s average salary at 136 million won was the highest among the surveyed companies. The average salary per employee was calculated by dividing the total paid out salary of respective companies last year by the number of employees, confirmed in the audit report. The figures were found in the ‘selling and administrative expense’ section of the submitted reports excluding benefit expense, bonus, incentives and severance payment. The wages of Korea Otsuka Pharmaceutical and Janssen Korea’s facility staffs were calculated from production cost and the wages of clinical trial staffs were calculated from R&D cost. Compared to the year before, GSK’s overall employment salary in 2019 has gone down by 1.8 percent at 59.8 billion won. In 2019, total 444 employees were reportedly working at GSK. Although the overall salary payout was lower than the year before, the number of employees went down as well in 2019 by 14, which increased the average salary per employee by 1.3 percent. Continuing from 2017 to last year, GSK has topped the highest salary rank for the multinational pharmaceutical companies in Korea. Compared to the runner-up Sanofi Pasteur, the gap between the two top companies’ average salary per employee is approximately 17 million won, which has been narrowed slightly from the previous year. The employees at Sanofi Pasteur have been paid the average salary of 119 million won last year. The number of employees was reduced from 65 in 2018 to 61 in 2019, but the total salary has gone up by 1.1 percent, bring up the average salary by 7.7 percent compared to the year before. The report analysis confirmed the average salary per employee at GSK Consumer Healthcare Korea (113 million won), Galderma Korea (112 million won), Allergan Korea (107 million won) and AbbVie Korea (102 million won) exceeded over 100 million won. More than half of the companies, 19 out of 31 multinational companies have paid out average salary of over 80 million won. As for Sanofi-Aventis Korea, last year’s average salary per employee was at 68 million won, reduced by 11.0 percent compared to the previous year at 76 million won. The multinational company has merged with Genzyme Korea last year and the number of employees has surged by 64 from 442 to 506. Considering the overall salary payout has gone up only by 1.9 percent from 33.73 billion won in 2018 to 34.37 billion won in 2019, the average salary per employee has technically gone down. However, the net pay per employee could have gone up depending on their respective performance. Sanofi-Aventis reported last year that it paid out bonus and extra pay (1 billion won) and incentives (2.6 billion won), besides the overall salary of 34.4 billion won, as personnel expenses. The employees at Genzyme Korea have received average salary of 73 million won last year, and the yearly comparison data is unavailable since the merge with Sanofi-Aventis. Among all 31 companies, employees at Janssen Vaccines have been paid the least with average salary of 4 million won. According to the report, the company has paid out overall 647 million won as personnel expenses for 145 employees, reported as of late last year. Since 2016, Janssen Vaccines has been in the red for four consecutive years. Regardless, the reported total personnel expenses are questionable, as the company intends to minimize operating personnel and reduce production volume while reorganizing the anticancer treatment and next-generation vaccine production lines. Moreover, the analysis is likely to be inaccurate in parts, because calculating the average salary by dividing the selling and administrative expense by the number of employees would not fully reflect the accurate figures of companies with production facility in Korea like Korea Otsuka Pharmaceutical and Janssen Korea, as they reflect the facility employee wage as production cost. Spun off from Pfizer Korea last year, Pfizer Upjohn Korea has reported overall personnel expenses of 15 billion won. Dividing the total by the number of employee reported late December, the 264 employees have received average salary of 57 million won per person. But as the report omitted the figures before the spin-off (May 27, 2019), the actual figure could differ from their net pay. Last year, Pfizer Korea has paid approximate average salary of 92 million won per employee, slightly lower than 97 million won in 2018 before the split with Pfizer Upjohn Korea.
- Opinion
- [FOCUS]We expect the MFDS to act wisely on impurity measures
- by Chon, Seung-Hyun Apr 22, 2020 06:02am
- At the end of September last year, when the MFDS decided to stop selling all products of the anti-ulcer drug “Ranitidine,” the pharmaceutical industry reacted strongly. The MFDS decided to withdraw because Ranitidine has unstable properties and is always exposed to the risk of carcinogenic substance 'N-nitrosodimethylamine (NDMA)'. The pharmaceutical industry complained strongly about tough measures in Korea, saying that we have not yet concluded whether or not the drug is harmful, and it is reasonable for NDMA to recover only the products in question that have been overdetected. At the time, in the United States and the EU, only the manufacturing number of products exceeding NDMA was recovered. Nevertheless, the MFDS was confident of the measures, saying that it has tested NDMA the most in the world. The Food and Drug Administration (FDA) decided to withdraw the Ranitidine product in the market on the 1st, about six months after that. The FDA concluded that the market withdrawal was justified for the reason that the impurities contained in some Ranitidine formulations could be detected over time to be acceptable. This is what gave the MFDS the decision made six months ago. Although the US action cannot be a barometer for judging the right or wrong of our government's decision, as a result, the MFDS was acknowledged that it took six months ahead of the US to proactively take scientific action. It should be praised enough. The complaints that the MFDS' follow-up to Ranitidine was overly impatient remained too hasty. In recent years, the pharmaceutical industry is paying great attention to the follow-up of NDMA for the diabetes treatment drug “Metformin”. In December of last year, the Singapore Health Sciences Authority (HSA) retrieved three products for the reason that NDMA exceeding the daily allowance was detected as a result of investigating 46 items of Metformin preparations on the market. In Canada, Metformin preparations from three pharmaceutical companies have voluntarily recovered due to NDMA detection for a month since February. In the United States and the EU, there is still an ongoing defense against Metformin's NDMA risk. The U.S. Food and Drug Administration (FDA) released a survey of 10 Metformin products in circulation in the U.S. in February, suggesting that NDMA was detected in two products, but no recall was recommended. However, a US private research firm, Valisure, proposed to the FDA earlier last month, announcing an analysis that NDMA exceeding the daily allowance was detected in some products of the drug 'Metformin' in circulation in the U.S. for diabetes. The European Medicines Agency (EMA) released its findings in an official statement on the 3rd of last month as soon as possible, and announced that imformation investigation results for Metformin are imminent, saying that patients with type II diabetes should continue taking Metformin until further announcement. It has been around four months since the Metformin NDMA risk in Singapore has risen, but the MFDS has never released an official position. Last year, the MFDS announced the results of an interim check that NDMA was not detected in domestic distribution products within three days after receiving the information about the detection of residual NDMA in the United States. Compared to this, the Metformin case doesn't seem to be quick. The MFDS received data on the use of Metformin in December last year from pharmaceutical companies. Metformin's NDMA test method was also released on January 15th. Earlier this year, we conducted a collection test for Metformin drug substance, and recently visited pharmaceutical companies to collect finished medicines. This is the point that the announcement of the Metformin inspection is imminent. Of course, it is expected that the MFDS will have great concerns. Metformin is the first and most widely used drug for people with type II diabetes, so it is a burden to take drastic measures like Valsartan and Ranitidine. Any follow-up can lead to extreme confusion among medical staff and patients. However, follow-up measures that apply different standards for different drugs can reduce trust in the government. However, if the collection inspection is over, follow-up should not be delayed. We look forward to wise follow-up by the MFDS based on scientific evidence. Transparency in the policy-making process can be supported by the people.
- Company
- Lipitor tops outpatient market again amid COVID-19
- by Chon, Seung-Hyun Apr 21, 2020 06:27am
- The 2019 novel coronavirus infection (COVID-19) seems to not have affected the top outpatient prescription drug rank in Korea. Dyslipidemia treatment Lipitor remained on the top of the leader board with a big gap. The prescription volumes of anticancer Tagrisso and cholesterol-lowering combination drug Rosuzet have also continued to skyrocket. But off-patent drugs that grew significantly in volume last year, actually showed an underwhelming growth. According to pharmaceutical industry research firm UBIST on Apr. 20, Pfizer’s dyslipidemia treatment Lipitor has made 47 billion won in the first quarter of the year, topping the outpatient prescription volume rank. Although the volume was 0.2 percent lower than last year’s first quarter, it easily defended the top place with almost double the volume of runner-up Tagrisso and Gliatamine. Comparison of prescription volume of major outpatient prescription drugs in first quarters of 2020 and 2019 (Source: UBIST) Lipitor, released in the Korean market in 1999, has been prescribed the most to outpatients for two consecutive years from 2018 to 2019. AstraZeneca’s anticancer treatment Tagrisso shined through in the market and ranked itself on the second place with 23.9 billion won in the quarter, surging by 18.2 percent from the previous year. It was exceptional for an anticancer treatment, mostly used for inpatient, to be ranked so close to the top. Tagrisso by AstraZeneca Tagrisso is a second-line therapy prescribed to patients with non-small cell lung cancer (NSCLC), who have developed resistance in existing epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKIs), such as Iressa, Tarceva and Giotrif. Overcoming the drug resistance issue, the drug has been labeled as a third-generation. Tagrisso’s prescription volume has been surging since it was listed for National Health Insurance (NHI) reimbursement in December 2017. The treatment’s outstanding effect, compared to other alternative options, and administrative convenience have seemingly accelerated the prescription volume growth. Rosuzet by Hanmi Pharmaceutical Skyrocketed by 27.4 percent from last year, Hanmi Pharmaceutical’s Rosuzet has achieved the highest annual growth among others reaching the prescription volume of 22.8 billion won in the first quarter this year. A rosuvastatin plus ezetimibe dyslipidemia-treating combination drug, Rosuzet was released to the market in late 2015. After acquiring the rights over ezetimibe from the patentee MSD, Hanmi Pharmaceutical was able to enter the market faster than other competitors and it has been predominantly leading the same-substance market ever since. The combination drug has made 81 billion won from prescription last year. Taking the rapid growth of Rosuzet into account, the sources even project the drug could be the first Korean-made drug to surpass annual prescription volume of 100 billion won. LG Chem’s combination agent diabetes drug Zemimet has made 15.6 billion won in the first quarter last year, and the volume was increased by 18.8 percent this year at 18.5 billion won. Zemimet has combined Zemiglo, a new diabetic drug with DPP-4 inhibitor solely developed by LG Chem, and metformin. A combination agent for dyslipidemia Atozet showed a 20.8-percent growth in prescription over a year and generated 17.9 billion won in the first quarter. Released by MSD in 2015, Atozet is an atorvastatin plus ezetimibe combination drug. Currently, Chong Kun Dang holds the co-sales deal signed by the multinational company. In the first quarter, off-patent drugs have shown stagnant growths. Boehringer Ingelheim’s hypertension treatment Twynsta has generated 23.6 billion won and made only 1.7-percent growth from the year before. The prescription volume of Sanofi’s anticoagulant drug Plavix grew 1.7 percent from the year before and marked 23.6 billion won in the quarter. Compared to last year, AstraZeneca’s dyslipidemia treatment Crestor and Gilead’s Viread have recorded 5.8 percent and 26.5 percent decrease in prescription volumes, respectively. The prescription volumes of Eisai’s Alzheimer’s disease treatment Aricept and of Astellas’ benign prostatic hyperplasia treatment Harnal-D also had each dropped by 5.7 percent and 8.5 percent. Except for Viread, these off-patented originals had a significant surge in prescription last year. In 2019, Lipitor has grown 8.4 percent from the year before and generated 176.2 billion won. Plavix’ prescription volume reached 88.9 billion won last year with 17.3 percent surge from the year before. Some original drugs like Crestor and Arisept marked a 10-percent growth in prescription volume last year, when Harnal-D also grew by 6.5 percent. However, the research firm analyzed the originals’ prescription volumes have diminished this year as the generics have performed better. The industry views that the continuous spread of COVID-19 has influenced the outpatient prescription market. When the multinational pharmaceutical companies preemptively stopped visiting healthcare institutes due to the outbreak, the Korean pharmaceutical companies could have persuaded the prescribers to switch to generics.
